Persantine

"A large-scale genomic analysis found that non-inherited mutations in hundreds of genes together account for about 1 in 10 cases of severe congenital heart defects. The findings bring us closer to understanding the most common type of birth defect"...

Persantine

WARNINGS

No information provided.

PRECAUTIONS

General

Coronary Artery Disease: Dipyridamole has a vasodilatory effect
and should be used with caution in patients with severe coronary artery disease
(e.g., unstable angina or recently sustained myocardial infarction). Chest pain
may be aggravated in patients with underlying coronary artery disease who are
receiving dipyridamole.

Hepatic Insufficiency: Elevations of hepatic enzymes and hepatic
failure have been reported in association with dipyridamole administration.

Hypotension: Dipyridamole should be used with caution in patients
with hypotension since it can produce peripheralvasodilation.

Laboratory Tests

Dipyridamole has been associated with elevated hepatic enzymes.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In studies in which dipyridamole was administered in the feed to mice (up to
111 weeks in males and females) and rats (up to 128 weeks in males and up to
142 weeks in females), there was no evidence of drug-related carcinogenesis.
The highest dose administered in these studies (75 mg/kg/day) was, on a mg/m2
basis, about equivalent to the maximum recommended daily human oral dose (MRHD)
in mice and about twice the MRHD in rats. Mutagenicity tests of dipyridamole
with bacterial and mammalian cell systems were negative. There was no evidence
of impaired fertility when dipyridamole was administered to male and female
rats at oral doses up to 500 mg/kg/day (about 12 times the MRHD on a mg/m2
basis). A significant reduction in number of corpora lutea with consequent reduction
in implantations and live fetuses was, however, observed at 1250 mg/kg (more
than 30 times the MRHD on a mg/m2 basis).

Pregnancy

Teratogenic Effects: PREGNANCY CATEGORY B

Reproduction studies have been performed in mice, rabbits and rats at oral
dipyridamole doses of up to 125 mg/kg, 40 mg/kg and 1000 mg/kg, respectively
(about 1 ½, 2 and 25 times the maximum recommended daily human oral dose, respectively,
on a mg/m2 basis) and have revealed no evidence of harm to the fetus
due to dipyridamole. There are, however, no adequate and well-controlled studies
in pregnant women. Because animal reproduction studies are not always predictive
of human response, Persantine (dipyridamole) should be used during pregnancy only if clearly
needed.

Nursing Mothers

As dipyridamole is excreted in human milk, caution should be exercised when Persantine (dipyridamole) tablets are administered to a nursing woman.

Pediatric Use

Safety and effectiveness in the pediatric population below the age of 12 years
have not been established.

Last reviewed on RxList: 4/18/2008
This monograph has been modified to include the generic and brand name in many instances.